Improving care for rural patients with solid tumors
Official title: Improving the Timeliness and Quality of Care for Rural Cancer Patients With Solid Tumors
Run by University of Colorado, Denver · NCT04916990 · Data updated 2026-11-12
This study is testing a new support program to see if it helps rural patients with solid tumors start and finish their treatment faster compared to usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 14 sites (Aurora, Colorado and 13 other locations) |
| Status | Recruiting |
| Started | September 1, 2022 |
| Main results expected | January 1, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT04916990 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old, English or Spanish speaking, diagnosed with specific types of solid tumors, and residing in designated rural areas served by participating hospitals.
✕Probably not a fit
Patients who do not reside in the specified rural counties or who are not diagnosed with the targeted solid tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the CARES intervention in enhancing the speed of treatment initiation and completion for patients with solid tumors in rural areas. A total of 320 participants will be randomly assigned to either the CARES intervention group, which includes navigation and counseling sessions, or a usual care group that receives standard resources. Participants will complete surveys to assess quality of care and patient-reported outcomes at baseline, 3 months, and 6 months. The intervention aims to provide tailored support through oncology nurse navigators and counselors over a 6-month period.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the time to treatment for rural patients diagnosed with solid tumors.
How similar studies have gone: Other studies have shown promising results with similar navigation and support interventions for cancer patients, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria Assessed During Screening:
1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Male and female adults over 18 years old
4. English or Spanish speaking
5. Receives cancer treatment at UCH- Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, or Parkview Medical Center.
6. Resides in any of the rural counties served by the UCH-Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, VA, Huntsman Cancer Institute, or Parkview Medical Center with Rural-Urban Continuum Codes (RUCC) codes 4-9.
7. Diagnosed with lung cancer (LC): small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), using incident LC diagnosis according to the International Classification of Diseases for Oncology \[ICD-O\] codes: C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and C33.9, and other lung cancer variants
8. Stage of diagnosis for SCLC (limited vs. extensive), NSCLC (Stages 0, I, II, IIA, IIIB, IV), according to the American Joint Committee on Cancer Staging \[AJCC\] Tumor Node Metastasis \[TNM\] stages: I-IV)
9. Will receive the following types of breast, bladder, cervix, colon, rectum, lung, head-and-neck cancer treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy)
10. Diagnosed with head and neck cancer (HNC) using head and neck squamous cell carcinoma (HNSCC) ICD-O codes for the oral cavity (including lip; codes C00.0-C00.6, C00.8, C00.9, C02.0-C02.3, C02.8, C0.2.9, C03.0, C03.1, C03.9-C04.1, C04.8-C05.0, C06.0-C06.2, C06.8, and C06.9), the oropharynx (codes C01.9, C02.4, C05.1, C05.2, C5.8, C5.9, C09.0, C09.1, C09.8-C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8), the hypopharynx (codes C12.9-C13.2, C13.8, and C13.9), and the larynx (codes C32.0- C32.3 and C32.8-C32.9) and histology codes for squamous cell carcinoma (SCC) or its variants (codes 8032, 8050, 8052, 8070-8075, and 8083-8084), and salivary gland cancer (code C07 and variants), and other head and neck cancer variants
11. Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV
12. Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants
13. Diagnosed with BC using malignant neoplasm of breast ICD-O codes for connective tissue of the breast, codes: C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C50.9, and other breast cancer variants.
14. Diagnosed with CC using malignant neoplasm of cervix uteri ICD-O codes: C53.0, C53.1, C53.8, C53.9 and other cervical cancer variants.
15. Diagnosed with CRC using colon and rectum malignant neoplasm ICD-O codes for colon (codes: C18, C18.1, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9) and rectum (code C20), and other colon and rectum cancer variants.
16. Diagnosed with BLC using malignant neoplasm of ICD-O codes: C67.9 and other bladder cancer varients.
Inclusion Criteria Confirmed via Baseline Survey:
17. Rural and medically underserved, defined as meeting the following criteria:
* Rural: Resides in a rural county with a RUCC code 4-9 AND,
* Underserved population who come from counties meeting any of the "health professional shortage areas" OR "Medically Underserved Areas/Populations" AND/OR
18. Uninsured: No health insurance (public or private insurance) AND/OR
19. Underinsured: (c.1) Public insurance (e.g., Medicaid, Medicare Part B exclusive, VA) (c.2) 10% or more of annual income is spent on out-of-pocket medical expenses
Exclusion Criteria Assessed During Screening:
1. Children under 18 years old
2. Individuals who do not speak English or Spanish
3. Individuals not receiving cancer treatment at UCH (Aurora, Highlands Ranch, UCHealth North, UCHealth Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary's or Parkview Medical Center.
4. Diagnosed with primary cancer other than breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer or other type of cancer not listed in the inclusion criteria.
5. Diagnosed with a type of breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer listed under inclusion criteria but will not be treated at one of the collaborating hospital sites,
6. Has already initiated curative treatment for the current episode of cancer.
Exclusion Criteria Assessed via Baseline Survey:
7. Individuals from vulnerable populations (e.g., inmates or on probation, homeless\*, and pregnant\*)
8. Decisionally-challenged with cognitive or personality impairment, suicidal ideation or intoxication (alcohol or drugs) at the time of consent or endorsed in baseline survey that interfere with ability to participate in the study.
9. Unable to hear (not including individuals who can hear with an auditory aid).\*
10. Likely inability to track the individual over time (e.g. no permanent address at the time of consent) \*Individuals who become homeless, pregnant, or lose their hearing or permanent address after they have consented and/or assigned to study condition may remain in the study until completion
Where it's running
-
University of Colorado Hospital
Aurora, Colorado, United States Recruiting -
Memorial Hospital Central
Colorado Springs, Colorado, United States Recruiting -
Memorial Hospital North
Colorado Springs, Colorado, United States Recruiting -
Poudre Valley Hospital
Fort Collins, Colorado, United States Recruiting -
SCL- St. Mary's Medical Center
Grand Junction, Colorado, United States Recruiting -
VA Western Colorado Health Care System
Grand Junction, Colorado, United States Recruiting
Show 8 more locations
-
Greeley Campus
Greeley, Colorado, United States Recruiting -
Highlands Ranch Hospital
Highlands Ranch, Colorado, United States Recruiting -
Medical Center of the Rockies
Loveland, Colorado, United States Recruiting -
San Juan Cancer Center
Montrose, Colorado, United States Recruiting -
Rocky Mountain Cancer Center
Pueblo, Colorado, United States Recruiting -
UCHealth - Parkview medical Center
Pueblo, Colorado, United States Recruiting -
Yampa Valley Medical Center
Steamboat Springs, Colorado, United States Recruiting -
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States Recruiting
Study contacts
- Principal investigator: Evelinn Borrayo, PhD — University of Colorado, Denver
- Study coordinator: Jennifer V Gonzalez, MS
- Email: jennifer.villalobosgonzalez@cuanschutz.edu
- Phone: 3037246278
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.